[Federal Register Volume 64, Number 107 (Friday, June 4, 1999)]
[Notices]
[Page 30041]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-14151]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-1541]


Draft Guidance for Industry on Establishing Pregnancy Registries; 
Availability

AGENCY: Food and Drug Administration, HHS

ACTION: Notice.

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SUMMARY: The Food and Drug Administration is announcing the 
availability of a draft guidance for industry entitled ``Establishing 
Pregnancy Registries.'' Pregnancy registries are recognized as one 
method of obtaining meaningful information on the risks associated with 
exposure to drugs or biologics during pregnancy. The draft guidance is 
intended to provide sponsors with guidance on establishing pregnancy 
registries that help ensure the quality and integrity of registry data 
and adequately document registry research methods. The draft guidance 
will be discussed during the June 3, 1999, meeting of the Subcommittee 
of the Advisory Committee for Reproductive Health Drugs.

DATES: Written comments may be submitted on the draft guidance document 
by September 2, 1999. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Copies of this draft guidance for industry are available on 
the Internet at ``http://www.fda.gov/cder/guidance/index.htm''. Submit 
written requests for single copies of the draft guidance to the Drug 
Information Branch (HFD-210), Center for Drug Evaluation and Research, 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. 
Submit written comments on the draft guidance to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852; or Office of Communication, Training and 
Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and 
Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, 
MD 20852-1448; http://www.fda.gov/cber/guidelines.htm; Fax: 1-888-
CBERFAX or 301-827-3844, Mail: the Voice Information System at 800-835-
4709 or 301-827-1800.

FOR FURTHER INFORMATION CONTACT: Rose E. Cunningham, Center for Drug 
Evaluation and Research (HFD-6), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5468; or Toni M. Stifano, 
Center for Biologics Evaluation and Research (HFM-602), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
3028, or via e-mail at ``[email protected]''.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
draft guidance for industry entitled ``Establishing Pregnancy 
Registries.''
    As part of its evaluation of pregnancy labeling, in September 1997 
the agency held a part 15 (21 CFR part 15) hearing on the current 
category requirements for pregnancy labeling (see 62 FR 41061, July 31, 
1997). The agency sought comment on the practical utility, effects, and 
limitations of the pregnancy categories. The agency also sought input 
on ways to address problems, including possible alternatives to the 
categories for communicating information on reproductive and 
developmental toxicity.
    Subsequently, the agency has been working on the development of 
various draft guidance documents, including the draft guidance for 
industry entitled ``Establishing Pregnancy Registries.'' At the time of 
marketing approval, FDA may request sponsors to conduct certain post-
marketing studies (phase 4) to provide data on the potential risks of 
the product in human pregnancy. Pregnancy registries are recognized as 
one method of obtaining information on risks associated with exposure 
to drugs or biologics during pregnancy.
     The draft guidance is intended to provide sponsors with guidance 
on establishing pregnancy registries that help ensure the quality and 
integrity of registry data and adequately document registry research 
methods. The draft guidance focuses on registries designed to assess 
products for suspected or unknown risks to pregnancy outcomes. The 
registry design is not appropriate for products (e.g., tretinoin or 
thalidomide) where the goal is to monitor and evaluate programs 
intended to prevent pregnancy exposures.
    The draft guidance will be discussed during the June 3, 1999, 
meeting of the Subcommittee of the Advisory Committee for Reproductive 
Health Drugs (64 FR 23340, April 30, 1999).
    This draft guidance is being issued consistent with FDA's good 
guidance practices (62 FR 8961, February 27, 1997). The draft guidance 
represents the agency's current thinking on establishing pregnancy 
registries. It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the requirements of the 
applicable statute, regulations, or both.
    Interested persons may submit written comments on the draft 
guidance to the Dockets Management Branch (address above). Two copies 
of any comments are to be submitted, except that individuals may submit 
one copy. Comments are to be identified with the docket number found in 
brackets in the heading of this document. The draft guidance and 
received comments are available for public examination in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: May 28, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy Coordination.
[FR Doc. 99-14151 Filed 6-3-99; 8:45 am]
BILLING CODE 4160-01-F